Treclin 10 mg/g + 0.25 mg/g Gel

*
Pharmacy Only: Prescription
  • Company:

    Mylan IRE Healthcare Ltd
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 01 November 2024

File name

ie-spc-se1134-v031-clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 01 November 2024

File name

ie-pl-se1134-v031-clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - how to report a side effect
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 09 July 2019

File name

ie-pl-se1134-v026g-clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 03 January 2019

File name

ie-pl-se1134-v025rtq-clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 03 January 2019

File name

ie-spc-se1134-v025rtq-clean.pdf

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 08 November 2018

File name

ie-pl-se1134-mahtransfer-clean.pdf

Reasons for updating

  • New PIL for new product

Updated on 07 November 2018

File name

ie-spc-se1134-mahtransfer-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 July 2016

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 July 2016

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 6.6: Special precautions for disposal has changed.

In section 10: The date of revision has been changed.

Updated on 15 July 2016

Reasons for updating

  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 6.6: Special precautions for disposal has changed.

In section 10: The date of revision has been changed.

Updated on 06 June 2016

Reasons for updating

  • Change to product name
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change to product name
date of revision changed

Updated on 06 June 2016

Reasons for updating

  • Change to product name
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Change to product name
date of revision changed

Updated on 13 January 2015

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.5: Information regarding clindamycin and Vitamin K antagonists has been added

In section 4.8: Statement regarding ADR reporting has been added

In section 10: date of revision has changed

Updated on 13 January 2015

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

In section 4.5: Information regarding clindamycin and Vitamin K antagonists has been added

In section 4.8: Statement regarding ADR reporting has been added

In section 10: date of revision has changed

Updated on 29 July 2014

Reasons for updating

  • Change to product name

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Correction of text in product name from

Treclinac I % w/w / 0.025 % w/w Gel

to

Treclinac l % w/w / 0.025 % w/w Gel

Updated on 29 July 2014

Reasons for updating

  • Change to product name

Free text change information supplied by the pharmaceutical company

Correction of text in product name from

Treclinac I % w/w / 0.025 % w/w Gel

to

Treclinac l % w/w / 0.025 % w/w Gel

Updated on 20 June 2014

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 20 June 2014

Reasons for updating

  • New SPC for new product

Free text change information supplied by the pharmaceutical company

None provided